Storage and handling
Other information store between 20-25°C (68-77°F)
Multi-Symptom Cold and Flu-Kids
- Manufacturer
- Genexa Inc.
- Effective date
- 2023-12-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 00:03:35
Label at a glance#
ProductMulti-Symptom Cold and Flu-Kids
Active ingredientGUAIFENESIN, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure12 sections
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each 10 mL)
Acetaminophen 320 mg
Dextromethorphan HBr, USP 5 mg
Guaifenesin, USP 100 mg
OTC - PURPOSE SECTION
Purposes
Pain Reliever/Fever Reducer
Cough suppressant
Expectorant
INDICATIONS & USAGE SECTION
Uses
• temporarily relieves:
• cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
• the intensity of coughing
• the impulse to cough to help your child get to sleep
• minor aches and pains associated with:
• the common cold • fever • sore throat
• headache • body pain
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of
bothersome mucus and make coughs more productive
WARNINGS SECTION
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes
• more than 5 doses in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
• skin reddening
• blisters
• rash
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
OTC - DO NOT USE SECTION
Do not use
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not
sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for
depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping
the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or
pharmacist before giving this product.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if the child has
• Liver disease
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm
(mucus) unless directed by a doctor.
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin
OTC - WHEN USING SECTION
When using this product do not use more than directed
OTC - STOP USE SECTION
Stop use and ask a doctor if
• pain gets worse or lasts more than 5 days
• fever gets worse or lasts more than 3 days
• new symptoms occur
• redness or swelling is present
• cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or
persistent headache.
These could be signs of a serious condition.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
OVERDOSAGE SECTION
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away
(1-800-222-1222). Prompt medical attention is critical even if you do not notice any signs or symptoms.
DOSAGE & ADMINISTRATION SECTION
Directions
• this product does not contain directions or complete warnings for adult use
• do not give more than directed (see Overdose warning)
• SHAKE WELL BEFORE USING
• find right dose on chart below
• for accurate dosing, use measuring cup provided.
Do not use with any other dosing device.
• give dose every 4 hours while symptoms last
• do not give more than 5 times in 24 hours
| children 6 to under 12 years | 10 mL every 4 hours |
| children 4 to under 6 years | 7.5 mL every 4 hours |
| children under 4 years | do not use |
STORAGE AND HANDLING SECTION
Other information
store between 20-25°C (68-77°F)
INACTIVE INGREDIENT SECTION
Inactive ingredients
organic agave syrup, organic blueberry flavor, natural citrus extract, natural flavor, purified water
OTC - QUESTIONS SECTION
Questions?
1-855-436-3921
SPL UNCLASSIFIED SECTION
SHAKE WELL before each use.
Bottle is safety sealed with a perforated band around bottle. DO NOT use if bottle seal is disturbed or missing.
Distributed by: Genexa Inc., Atlanta, GA 30324
genexa.com | U.S. Patent No. 11,617,795
SPL UNCLASSIFIED SECTION
Made in the USA with globally sourced ingredients
NDC 69676-0087-9
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Genexa®
MEDICINE MADE CLEAN
Ages 4+
Kids' Multi-Symptom Cold & Flu
Acetaminophen 320 mg - Pain Reliever/Fever Reducer
Dextromethorphan HBr 5mg - Cough Suppressant
Guaifenesin 100 mg - Expectorant
Cough
Mucus
Chest Congestion
Sore Throat
Fever
Body Pain
Medicine made clean
Same effective active ingredients, but no artificial fillers.
Organic Blueberry Flavor
4 FL OZ (118 mL) Liquid
Dosing cup included
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2644702 | acetaminophen 320 MG / dextromethorphan HBr 5 MG / guaiFENesin 100 MG in 10 mL Oral Suspension | PSN | 3 |
| 2644702 | acetaminophen 32 MG/ML / dextromethorphan hydrobromide 0.5 MG/ML / guaifenesin 10 MG/ML Oral Suspension | SCD | 3 |
| 2644702 | acetaminophen 320 MG / dextromethorphan HBr 5 MG / guaifenesin 100 MG per 10 ML Oral Suspension | SY | 3 |
| 2644702 | APAP 32 MG/ML / dextromethorphan hydrobromide 0.5 MG/ML / guaifenesin 10 MG/ML Oral Suspension | SY | 3 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69676-0087-9 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-b39f-d83d-e063-dadaa90ab31f | Kids' Multi-symtpom Cold and Flu |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69676-0087-9 | Multi-Symptom Cold and Flu-Kids | 1 in 1 CARTON | SUSPENSION | 1 | 3 | |
| 69676-0087-9 | Multi-Symptom Cold and Flu-Kids | 118 mL in 1 BOTTLE | SUSPENSION | 118 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69676-0087 | MULTI-SYMPTOM COLD AND FLU-KIDS (ACETAMINOPHEN 320 MG, DEXTROMETHORPHAN HBR 5 MG, GUAIFENESIN 100 MG) SUSPENSION [GENEXA INC.] | 3 | 2 package rows | 20231208_027469db-7d2e-753b-e063-6294a90a4355.zip |
Products#
Every source-derived product name is available through these pages.
- Multi-Symptom Cold and Flu-Kids
- Acetaminophen 320 mg, Dextromethorphan HBr 5 mg, Guaifenesin 100 mg
- GUAIFENESIN
- ACETAMINOPHEN
- CITRUS FRUIT
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- AGAVE TEQUILANA JUICE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69676-0087 | 69676-0087-9 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GUAIFENESIN | 495W7451VQ | ACTIB |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| CITRUS FRUIT | XDK00Z8012 | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| AGAVE TEQUILANA JUICE | GVG8G0207O | IACT |
| WATER | 059QF0KO0R | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 0bf12c6e-a370-7f42-e063-6294a90a7a42 | 027469db-7d2e-753b-e063-6294a90a4355 | 2023-12-07 | Warnings | 0bf12c6e-a370-7f42-e063-6294a90a7a42 027469db-7d2e-753b-e063-6294a90a4355 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.